Improving access to breast cancer screening and treatment in Nigeria: The triple mobile assessment and patient navigation model (NCT05321823): A study protocol.

BACKGROUND: In Nigeria, breast cancer incidence is rising, late presentation is common, and outcomes are poor. Patient-related factors such as lack of awareness and misperceptions in addition to health system deficiencies such as lack of a clearly defined framework for breast cancer screening and referral are some of the major drivers of this poor outlook. Guidelines for breast cancer screening in high-income countries have limited applicability in low-middle-income countries, hence the need for innovative, resource-compatible strategies to combat the negative trend. This manuscript presents our study protocol which aims to evaluate the impact of a novel breast cancer early detection program developed to address delayed presentation and lack of access to diagnostic and treatment facilities in South-West Nigeria. This entails the use of mobile technology (innovative handheld iBreast Exam [iBE] device, mobile breast ultrasound, and mobile mammography) and patient navigation as interventions at the community level. METHODS: The study (ClinicalTrials.gov identifier: NCT05321823) will adopt a randomized two group clinical trial design with one local government area (LGA) serving as an intervention arm and another serving as the control. Both LGAs will receive breast cancer awareness education but only one will receive the interventions. In the intervention arm, asymptomatic (40-70 years) and symptomatic (30-70 years) women will be invited for breast evaluation which will be performed by trained Community Health Nurses using Clinical Breast Exam (CBE), and iBE. Those with positive findings will proceed to imaging using mobile mammography and ultrasound brought to the LGA every month. Symptomatic women with negative findings on CBE and iBE will be scheduled for repeat clinical evaluation on a short-term basis (one month). The Radiologist will obtain core needle biopsies as indicated and transfer them for prompt pathological assessment. Women presenting to the Primary Healthcare Centers in the control LGA will be referred directly to Obafemi Awolowo University Teaching Hospitals Complex as per the current standard of care. Records of all breast cancer cases seen in the two LGAs during the study period will be obtained. The program metrics will include screening participation rate, cancer detection rate, stage at diagnosis, and timeline from detection to initiation of treatment. The stage at diagnosis and timeline from detection to treatment compared between the two LGAs will be used to assess the impact of the intervention. The study is proposed for 2 years; however, a descriptive analysis will be carried out at 1.5 years to evaluate the retention of the study participants. STUDY SIGNIFICANCE: It is anticipated that this study will provide vital data to support wider breast cancer screening efforts in Nigeria.

Can Follow-up be Avoided for Probably Benign US Masses with No Enhancement on MRI?

OBJECTIVES: To assess whether no enhancement on pre-treatment MRI can rule out malignancy of additional US mass(es) initially assessed as BI-RADS 3 or 4 in women with newly diagnosed breast cancer. METHODS: This retrospective study included consecutive women from 2010-2018 with newly diagnosed breast cancer; at least one additional breast mass (distinct from index cancer) assigned a BI-RADS 3 or 4 on US; and a bilateral contrast-enhanced breast MRI performed within 90 days of US. All malignant masses were pathologically proven; benign masses were pathologically proven or defined as showing at least 2 years of imaging stability. Incidence of malignant masses and NPV were calculated on a per-patient level using proportions and exact 95% CIs. RESULTS: In 230 patients with 309 additional masses, 140/309 (45%) masses did not enhance while 169/309 (55%) enhanced on MRI. Of the 140 masses seen in 105 women (mean age, 54 years; range 28-82) with no enhancement on MRI, all had adequate follow-up and 140/140 (100%) were benign, of which 89/140 (63.6%) were pathologically proven and 51/140 (36.4%) demonstrated at least 2 years of imaging stability. Pre-treatment MRI demonstrating no enhancement of US mass correlate(s) had an NPV of 100% (95% CI 96.7-100.0). CONCLUSIONS: All BI-RADS 3 and 4 US masses with a non-enhancing correlate on pre-treatment MRI were benign. The incorporation of MRI, when ordered by the referring physician, may decrease unnecessary follow-up imaging and/or biopsy if the initial US BI-RADS assessment and management recommendation were to be retrospectively updated. KEY POINTS: • Of 309 BI-RADS 3 or 4 US masses with a corresponding mass on MRI, 140/309 (45%) demonstrated no enhancement whereas 169/309 (55%) demonstrated enhancement • All masses classified as BI-RADS 3 or 4 on US without enhancement on MRI were benign • MRI can rule out malignancy in non-enhancing US masses with an NPV of 100.

In vivo magnetic resonance imaging and optical imaging comparison of viable and nonviable mesenchymal stem cells with a bifunctional label.

The purpose of this study was to compare viable and nonviable bilabeled mesenchymal stem cells (MSCs) in arthritic joints with magnetic resonance imaging (MRI) and optical imaging (OI). MSCs were labeled with ferucarbotran and DiD. MRI and OI of bilabeled cells were compared with controls. Six rats with arthritis received intra-articular injections of bilabeled viable MSCs into the right knee and nonviable MSCs into the left knee. Animals underwent MRI and OI preinjection and at 4, 24, 48, and 72 hours postinjection. The results were analyzed with a mixed random effects model and Fisher probability. Bilabeled MSCs showed increased MRI and OI signals compared to unlabeled controls (p < .0001). After intra-articular injection, bilabeled MSCs caused significant T2 and T2* effect on MRI and fluorescence on OI up to 72 hours postinjection (p < .05). There was no significant difference between viable and nonviable MSC signal in the knee joints; however, some of the viable cells migrated to an adjacent inflamed ankle joint (p < .05). Immunohistochemistry confirmed viable MSCs in right knee and ankle joints and nonviable MSCs in the left knee. Viable and nonviable cells could not be differentiated with MRI or OI signal intensity but were differentiated based on their ability to migrate in vivo.